Job Responsibilities 工作職責:
1. To be responsible for tech transfer on behalf of MFG USP/DSP.
代表上游/下游生產負責技術轉移;
2. Participate in the evaluation of new technology, new production
process and new production technology.
參與評估新工藝、新生產流程和新生產技術;
3. Make project BOM per required; Draft MPI and BPR per the process.
根據要求起草項目BOM;根據工藝要求寫工藝規程和批記錄;
4. As the representative of the production department, handle material qualification and supplier qualification.
作為生產部的代表處理物料確認和供應商確認;
5. As a representative of the production department, respond to quality audits from the administrative supervision departments and customers.
作為生產部代表應對來自行政監管部門和客戶的質量審計;
Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams.
根據需要參與公司的內部審計計劃;能夠擔任跨職能團隊的部門代表;
6. Deal with quality events in the production department, including deviations, change control, CAPA, EC, risk assessments, etc.
處理生產部的質量事件,包括偏差,變更,預防糾正措施,有效性檢查,風險評估等;
7. Lead the equipment validation and Re-qualification work
主導設備驗證和再確認工作。
Qualification 任職資格:
1. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
能夠撰寫詳細的報告和總結,并展示注重細節的文檔技能;
2. Communicate effectively and work professionally in a team environment.
善于在團隊中進行有效的溝通和專業的工作;
3. Familiarity of computer-based systems.
熟悉計算機系統;
4. Oral and written communication skills in Chinese and English (Read, Write, Verbal).
良好的中英文讀寫和溝通能力;
5. Degree of junior college or above in Chemistry, Chemical Engineer, Life sciences or relevant background.
??萍耙陨蠈W歷,化學、化學工程、生命科學或者相關專業;
6. Basic knowledge and understanding of biopharmaceutical technology, especially the process of monoclonal antibodies or recombinant fusion protein drugs.
對于生物制藥技術有一定了解,特別是單克隆抗體或者重組融合蛋白藥物的工藝流程。